PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Xcovery,
a developer of targeted therapeutics for cancer, announced the
initiation of its Phase 2 clinical trial of ensartinib (X-396), the
company’s lead anaplastic lymphoma kinase (ALK) drug candidate, in
patients with advanced malignant melanoma harboring alterations in ALK,
including ALKATI. The trial is being conducted by the
renowned Memorial Sloan Kettering Cancer Center (MSK) and led by MSK’s
Dr. Alexander Shoushtari.

The primary objective of the study is to determine the clinical benefit
rate (CBR) of ensartinib in this patient population. CBR is defined as
any confirmed objective response by Response Evaluation in Solid Tumors
(RECIST) 1.1 or stable disease until the 24-week assessment. This is an
open label, single arm Phase 2 study, enrolling patients with melanoma
either currently or previously having received a PD-1 based therapy and,
if BRAF V600 mutated, a BRAF-based therapy. The study is comprised of
two portions: the screening phase and treatment phase. In the screening
phase, archival tumor tissues from patients deemed to be current or
future candidates for this trial will be tested for the ALKATI
alteration using a Nanostring-based RNA assay at MSK. Patients whose
tumors express ALKATI will be eligible for the treatment
phase.

“While there has been significant clinical advancements in the treatment
of advanced malignant melanoma, 30 to 40 percent of patients do not
respond to immune-based therapy or will develop therapeutic resistance.
This is a promising trial that uses an RNA-based assay to identify an
epigenentically-regulated tumor growth mechanism and if deemed favorable
for further study, this trial could represent a new treatment option for
patients who currently have few options,” said Alexander Shoushtari,
M.D., Department of Medicine/Melanoma and Immunotherapeutics Services
and principal investigator of the study at MSK.

“We are honored to collaborate with the distinguished scientists and
investigators at MSK who were the first to discover this novel ALK
alternation in melanoma patients,” said Lieming Ding, M.D., Chairman of
Xcovery. “We hope that ensartinib will be a viable treatment option for
these patients.”

About XcoveryXcovery is a biopharmaceutical company working
to improve the lives of patients with cancer by discovering medicines to
fight advanced tumors. Xcovery is developing a pipeline of oncology
therapies to target a wide range of advanced tumors. For more
information, visit www.xcovery.com.

Forward‐Looking StatementsThis press release contains
forward‐looking statements that are based on company management’s
current beliefs and expectations and are subject to currently unknown
information, risks and circumstances and actual results may vary from
what is being currently projected.